Events

Retiro De Equipo (Recall) de VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ortho-Clinical Diagnostics Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00736-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-29
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00736-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Ortho clinical diagnostics australia has identified the potential for positively biased sample results to occur when using certain vitros na+ slides. results for serum/plasma and urine samples obtained using impacted vitros na+ slides may be positively biased and quality control fluids may be outside of the expected ranges. the amount of bias in the vitros na+ method is dependent upon multiple sources of variability.Two separate issues have been identified:- vitros na+ slides, gens 8 & 13: positively biased urine sample results; and - vitros na+ slides, gens 13, 14, 16, 17 & 18: positively biased serum or plasma sample results.
  • Acción
    Ortho Clinical Diagnostics is advising: For VITROS Na+ Slides, GENs 8 & 13: - Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 8 & 13, regardless of sample type used for testing. For VITROS Na+ Slides, GENs 14, 16, 17 & 18: - Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 14, 16, 17 & 18, regardless of sample type used for testing. - It is acceptable to continue to use remaining slides until your replacement order arrives provided both of the following criteria are met: 1. Calibration is successful and Quality Control results are within acceptable limits; and 2. Distribution of normal results for serum or plasma samples are centred within the established reference interval for the laboratory. If at any time during use of remaining slides, any of the above criteria are no longer met, discontinue use and notify the requesting physician for all previously reported Na+ results that are likely affected where applicable.

Device

VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)Product Code:8379034Affected Generations: GENs: 8, 13, 14, 16, 17, 18Expiry Dates: 01-Nov-2018 through 01-Nov-2019ARTG Number: 232249(Ortho-Clinical Diagnostics Australia Pty Ltd - Clinical chemistry electrolyte IVDs)
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd